Natural Killer (NK) Cell Adback After Allogeneic Stem Cell Transplant With Campath-IH Plus Chemorx for Patients With Lymphoid Malignancies

Summary

Primary objective:

* To determine the safety of adback T- or Natural Killer (NK) cells in patients with lymphoid malignancies receiving allogeneic stem cell transplantation with Campath-IH containing conditioning regimen.

Secondary objective:

* To determine the efficacy (disease-free-survival) of this strategy.

Conditions

• Lymphoma
• Leukemia

Interventions

DRUG

ARA-C

100 mg/m\^2 IV Daily Over 1 Hour for 4 Days

DRUG

BCNU

300 mg/m\^2 IV Over 1 Hour for 1 Day

DRUG

Campath-1H

15 mg IV Daily Over 30 Minutes for 3 Days

DRUG

Cyclophosphamide

1000 mg/m\^2 IV Daily Over 1 Hour for 3 Days

DRUG

Etoposide

100 mg/m\^2 IV Daily Over 3 Hours for 4 Days

DRUG

Fludarabine

30 mg/m\^2 IV Daily Over 1 Hour for 3 Days

DRUG

Melphalan

100 mg/m\^2 IV Over 30 Minutes for 1 Day.

DRUG

Rituximab

375 mg/m\^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m\^2 IV Over 5-7 Hours Weekly for 3 Weeks.

OTHER

Allogeneic Stem Cell Transplantation

Stem Cell Infusion on Day 0.

RADIATION

Total body radiation (TBI)

TBI on Day 5 following chemotherapy, before stem cell infusion.

DRUG

Methotrexate

5 mg/m2 IV on Days +1, +3, and +6.

DRUG

Tacrolimus

0.03 mg/kg/day IV starting on Day -2, to be given through day 60, tapered by 20% every week, then discontinue by day 90.

PROCEDURE

Adback NK or T Cell

Adback natural killer (NK) cells or T cells after transplantation to enhance full engraftment of donor cells. Cell adback after transplantation applies only if there is no active GVHD, and no previous episode of grade II-IV GVHD.

Sponsors & Collaborators

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Issa F. Khouri, MD · M.D. Anderson Cancer Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-09-30

Primary Completion

2010-11-30

Completion

2010-11-30

Countries

• United States

Study Locations